Evaluating Commercial Anti-Plaque Products and Oral Rinse

Dental Plaque Clinical Trial

Official title:

Evaluating Commercial Anti-Plaque Products and Oral Rinse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014143
• Other study ID #: CRO-2007-PLA-15-RR
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2008
• Last updated: June 10, 2011
• Start date: August 2007
• Est. completion date: September 2007

Study information

• Verified date: June 2011
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

Description:

This clinical research study was to train new examiners for short term plaque clinical methodologies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 81 Years

Eligibility

Inclusion Criteria:

• Male or female volunteers at least 18 years of age.

• Good general health.

• Must sign informed consent form.

• Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.

• No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

• Subjects unable or unwilling to sign the informed consent form.

• Medical condition which requires pre-medication prior to dental visits/procedures.

• Moderate or advanced periodontal disease or heavy dental tartar (calculus).

• Two or more decayed untreated dental sites at screening.

• Other disease of the hard or soft oral tissues.

• Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

• Use of medications that are currently affect salivary function.

• Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

• Allergy to chlorhexidine.

• Pregnant or nursing women.

• Participation in any other clinical study within 1 week prior to enrollment into this study.

• Use of tobacco products.

• Subjects who must receive dental treatment during the study dates.

• Current use of Antibiotics for pre-medication for dental treatment or for any other purpose.

• Presence of an orthodontic appliance that interferes with plaque scoring.

• History of allergy to common dentifrice ingredients.

• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Drug:
• Fluoride
Half mouth toothbrushing twice a day for four days.
• Chlorhexidine digluconate
Mouth rinsing with 15 ml for 30 seconds twice a day for four days.
• Fluoride, triclosan
Half mouth Brushing twice daily

Locations

Country	Name	City	State
United States	New Institutional Service Company	Northfield	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Index	Plaque scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)	Four days	No